Device and process to confirm occlusion of the fallopian tube

Abstract

A device is provided to confirm intratubal occlusion in a subject of a fallopian tube having an inner diameter that includes a tubular shaft having a distal end and an interior lumen. An examination head is joined to the distal end of the shaft. A visualization modality in the examination head provides visual or acoustic imaging of the fallopian tube. A power source for the visualization modality is provided. A handle is provided for control of the device. An ex vivo imager of an ocular, video headgear, or a video display is provided in communication with the visualization modality. A process for evaluating an intratubal implant in a fallopian tube through optical or sonic wave visualization is also provided.

1 . A device to confirm intratubal occlusion in a subject of a fallopian tube having an inner diameter, said device comprising:
 a tubular shaft having a distal end and an interior lumen;   an examination head joined to the distal end of said shaft;   a visualization modality in said examination head for visual or acoustic imaging of the fallopian tube;   a power source for said visualization modality;   a handle for control of said device and for support; and   an ex vivo imager of an ocular, video headgear, or a video display in communication with said visualization modality.   
     
     
         2 . The device of  claim 1  wherein said tubular shaft has a first outer diameter and said examination head has a second outer diameter that is greater than the first outer diameter designed to fit against the inner diameter of the fallopian tube lumen wherein said first outer diameter is 1.8 mm. 
     
     
         3 . The device of  claim 2  further comprising a rear taper transition between the first outer diameter and the second outer diameter. 
     
     
         4 . The device of  claim 1  further comprising a front taper transition extending from said examination head to a front tip of said examination head. 
     
     
         5 . The device of  claim 1  wherein said smooth outer surface is coated with a lubricating substance. 
     
     
         6 . The device of  claim 1  wherein said visualization modality includes an ultrasonic transducer. 
     
     
         7 . The device of  claim 1  wherein said visualization modality includes an ultrasonic transducer and further comprising a reservoir of fluid for delivering said fluid to a volume between said ultrasound transducer and the inner diameter of the fallopian tube. 
     
     
         8 . The device of  claim 1  wherein said imager is in wireless communication with said visualization modality. 
     
     
         9 . The device of  claim 1  wherein said visualization modality is visual and a fiber optic providing an image to said imager through the interior lumen of said shaft. 
     
     
         10 . The device of  claim 9  further comprising at least one fiber end terminating in said examination head and coupled to a light source for lighting the fallopian tube. 
     
     
         11 . The device of  claim 1  wherein said visualization modality is Intravascular Ultrasound (IVUS). 
     
     
         12 . The device of  claim 1  further comprising a working channel extending through the interior lumen to said examination head. 
     
     
         13 . The device of  claim 12  further comprising one of a solid guide wire, hollow guide wire, or a manipulator sliding within said working channel to extend from said examination head. 
     
     
         14 . The device of  claim 1  wherein said visualization modality is optical and is Optical Coherence Tomography (OCT). 
     
     
         15 . The device of  claim 1  further comprising a catheter having an end and a bore proportioned to receive said shaft such that said examination head extends to the end of said catheter, the end terminates in a sonically transparent balloon adapted to insert with the inner diameter of the fallopian tube. 
     
     
         16 . The device of  claim 15  wherein said shaft is configured to slide in the working channel of a hysteroscope. 
     
     
         17 . A process of evaluating an intratubal implant in a fallopian tube comprising:
 inserting the device according to  claim 1  into proximity to the fallopian tube; and   visualizing the intratubal implant.